RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and etoposide, in treating patients who have stage III non-small cell lung cancer and Pancoast tumors.

Condition	Treatment or Intervention	Phase
stage IIIA non-small cell lung cancer Adenosquamous Cell Lung Cancer Squamous Cell Lung Cancer stage IIIB non-small cell lung cancer Adenocarcinoma of the Lung large cell lung cancer	Drug: cisplatin  Drug: etoposide	Phase II

Further Study Details: 

OBJECTIVES: I. Assess the feasibility and toxic effects of 2 courses of cisplatin/etoposide given concurrently with continuous, fractionated chest irradiation followed by surgical resection and boost chemotherapy in patients with Pancoast tumors without mediastinal or supraclavicular nodal involvement.

II. Assess the objective response rate, resectability rate, and proportion of patients free of microscopic residual disease after such treatment.

PROTOCOL OUTLINE: All patients receive Induction on Regimen A and, in the absence of progression, proceed to Regimen B, then C. Patients who refuse or are medically unfit for surgery following Regimen A proceed directly to Regimen C.

Regimen A: 2-Drug Combination Chemotherapy plus Radiotherapy. Cisplatin, CDDP, NSC-119875; Etoposide, VP-16, NSC-141540; plus irradiation of the tumor and ipsilateral supraclavicular region using megavoltage equipment (photons with peak energies of 4-15 MV).

Regimen B: Surgery. Tumor resection.

Regimen C: 2-Drug Combination Chemotherapy. CDDP; VP-16.

PROJECTED ACCRUAL: 99 patients will be accrued over 2-4 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically proven non-small cell lung cancer of any type
• Selected stage IIIA/B disease (T3-4, N0-1, M0) with superior sulcus involvement, including: Apical tumor without rib or vertebral body involvement, with Pancoast syndrome; Superior sulcus tumor with involvement of the chest wall (T3) and usually ribs 1 and 2 by CT or MRI, with or without Pancoast syndrome; Superior sulcus tumor with involvement of vertebral body or subclavian vessels (T4) by CT or MRI, with or without Pancoast syndrome
• Pancoast syndrome defined: Arm or shoulder pain; Neurologic findings corresponding to C8 and T1 roots or the inferior trunk of the brachial plexus, with or without Horner's syndrome
• Single primary lesion that is measurable or evaluable by chest x-ray or CT required
• Pleural effusions allowed only if: Transudate with negative cytology on 2 separate thoracenteses if present before mediastinoscopy or exploratory thoracotomy; Transudate or exudate with negative cytology on a single thoracentesis if present only after preregistration exploratory or staging thoracotomy OR Present on CT but not chest x-ray AND considered too small to tap under CT or ultrasound guidance; Thoracoscopy to assess pleural metastases strongly recommended
• No mediastinal or supraclavicular nodal involvement (N2-3) established by mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy; No documented single- or multi-level ipsilateral or contralateral mediastinal nodes whether or not enlarged nodes visible on chest x-ray or CT; AP window nodes (level 5) causing vocal cord paralysis considered N2 disease in patients with a distinct primary tumor in the left upper lobe; Paralysis documented by indirect laryngoscopy
• No evidence of distant metastases on the following: Chest CT, preferably with contrast; Thoracic spine MRI strongly recommended if CT suggests vertebral body invasion; Abdominal CT including liver and adrenals, preferably with contrast; Biopsy or aspiration cytology required to confirm diagnosis of any CT or MRI abnormality; MRI and ultrasound sufficient to diagnose benign cysts or hemangiomas; Brain CT or MRI with contrast; Bone scan with x-rays or MRI, and/or aspiration cytology of any abnormality (unless related to chest wall extension of primary)
• No pericardial effusions or superior vena cava syndrome
• Patient considered candidate for potential pulmonary resection by attending thoracic surgeon

--Prior/Concurrent Therapy--

• No prior chemotherapy or radiotherapy for lung cancer; Prior exploratory thoracotomy allowed only for diagnostic or staging purposes

--Patient Characteristics--

• Age: Adult
• Performance status: SWOG 0-2; Albumin at least 0.85 times normal and no greater than 10% tumor-related weight loss required in patients with performance status 2
• Hematopoietic: WBC at least 4,000; Platelets at least normal
• Hepatic: (unless abnormality due to documented benign disease) Bilirubin no greater than 1.5 times normal; ALT or AST no greater than 1.5 times normal
• Renal: Creatinine clearance (calculated) at least 50 mL/min
• Cardiovascular: No poorly controlled disease, e.g.: Myocardial infarction within 3 months Active angina; Arrhythmia; Clinically evident congestive heart failure
• Pulmonary: FEV1 at least 2.0 liters OR Predicted postresection FEV1 greater than 800 mL based on quantitative lung V/Q scan; DLCO at least 50% of predicted (corrected for hemoglobin) and recommended if pneumonectomy planned
• Other: No symptomatic peripheral neuropathy; No peptic ulcer disease unless medically controlled; Acceptance of potential worsening of any existing clinical hearing loss; No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer; Adequately treated in situ cervical cancer; No pregnant or nursing women; Effective contraception required of fertile women

Tennessee
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States

Study chairs or principal investigators

Charles A. Coltman, Jr.,  Study Chair,  Southwest Oncology Group   
David Horton Johnson,  Study Chair
Richard L. Schilsky,  Study Chair
Ronald L. Burkes,  Study Chair
Michael J. O'Connell,  Study Chair

Study ID Numbers:  CDR0000064135; SWOG-9416; INT-0160; CAN-NCIC-BR11; CLB-9495; E-S9416; NCCTG-9416
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002642
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08